MAUDE Adverse Event Report: COOK, INC. COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Model Number N/A

Device Problems Other (for use when an appropriate device code cannot be identified) (2203); Appropriate Term/Code Not Available (3191)

Patient Problem Necrosis (1971)

Event Type  Injury  

Event Description

The reporter states that a bakri was left indwelling beyond what is indicated on the instructions for use (ifu) leading to necrosis.The reporter could not confirm when this event occurred nor if any intervention was performed.Add'l info has been requested but not provided at the time of this report.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable or unchanged.Patient code: necrosis is not labeled in the ifu.Device code: prolong indwelling is labeled in the ifu.Investigation - evaluation a review of the complaint history, instructions for use (ifu), quality control and trends was conducted during the investigation.The device is shipped with an ifu that describes the intended use, specific items are addressed such as: "the device should not be left indwelling for more than 24 hours.Patient monitoring is an integral part of managing postpartum hemorrhage.Signs of deteriorating or non-improving condition should lead to a more aggressive treatment and management of patient uterine bleeding." the ifu states the following under the balloon removal section, "note: the timing of balloon removal should be determined by the attending clinician upon evaluation of the patient once bleeding has been controlled and the patient has been stabilized.The balloon may be removed sooner upon the clinician's determination of hemostasis.The maximum indwell time is 24 hours." the complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.It is likely that the necrosis occurred due to the device remaining in the patient for more than 24 hours against the statements in the ifu.Leaving the device in for more than 24 hours can cause prolonged pressure on the tissue which may lead to necrosis.Based on the information provided, and the results of our investigation the most likely cause of the necrosis was failure to follow instructions and/or label copy.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the health risk assessment, no further action is required.

Event Description

The reporter states that a bakri was left indwelling beyond what is indicated on the instructions for use leading to necrosis.The reporter could not confirm when this event occurred nor if any intervention was performed.Additional information has been requested but not provided at the time of this report.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4853552
• MDR Text Key: 21120370
• Report Number: 1820334-2015-00361
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-SOSR-100500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 06/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other